GLOFIL-125: Package Insert and Label Information (Page 2 of 2)

Radiation Dosimetry

The estimated absorbed radiation doses to an average (70 kg) patient from an intravenous dose of 100 μCi (3.7 megabecquerels) of GLOFIL^® -125 are shown in Table 4. Calculations assume that there is 1% free iodide in the preparation and that the thyroid uptake of the iodine is 25%.

Table 4. Absorbed Radiation Doses *

* Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, Oak Ridge, TN, 1988.
	Absorbed radiation doses for 100 µCi (3.7 megabecquerels)
	2 hour bladder voiding interval		4.8 hour bladder voiding interval
Organ	rads	mGy	rads	mGy
Lower Large Intestine Wall	0.00065	0.0065	0.0012	0.012
Small Intestine	0.00044	0.0044	0.00050	0.0050
Stomach	0.00047	0.0047	0.00047	0.0047
Upper Large Intestine Wall	0.00040	0.0040	0.00044	0.0044
Kidneys	0.0064	0.064	0.0064	0.064
Liver	0.0018	0.018	0.0018	0.018
Ovaries	0.00054	0.0054	0.00085	0.0085
Testes	0.0019	0.019	0.0021	0.021
Urinary Bladder Wall	0.022	0.22	0.06	0.6
Red Marrow	0.00033	0.0033	0.00034	0.0034
Thyroid	0.78	7.8	0.78	7.8
Total Body	0.00096	0.0096	0.0011	0.011

Visual Inspection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Identity

No. 1000, GLOFIL^® -125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.

Storage

Refrigerate the product upon receipt at 2°C to 8°C.

Dose Volume Calculation

Table 3 provides the required factors for the determination of activity per mL post calibration date for GLOFIL^® -125 sterile solution.

To determine the dose volume, locate the decay factor (fraction remaining) which corresponds to the day that the dose is to be administered. The following equation is then utilized to determine the dose volume:

(activity of desired dose) /[(decay factor) x (amount of activity/mL on calibration day)] = dose volume (mL) (information on label)

REFERENCES

1. Sigman EM, Elwood CM, Reagan ME, Morris AM, Catanzaro A. The renal clearance of ¹³¹ I labeled sodium iothalamate in man. Invest Urol 1965; 2:432.
2. Cohen ML, Smith FG Jr., Mindell RS, Vernier RL. A simple reliable method of measuring glomerular filtration rate using single low dose sodium iothalamate ¹³¹ I.Pediatrics 1969; 43:407.

ADDITIONAL REFERENCES

3.

Maher FT, Nolan NG, Elveback LR. Comparisons of simultaneous clearances of ¹²⁵ I-labeled sodium iothalamate (Glofil) and of Inulin. Mayo Clin Proc 1971; 46: 690-691.

4.

Skov PE. Glomerular filtration rate in patients with severe and very severe renal insufficiency. Acta Med Scand 1970; 187: 419-428.

Manufactured by Iso-Tex Diagnostics, Inc. for QOL Medical

QOL Medical

Kirkland, WA 98033

Phone 1-866-469-3773

Revised April 2006

No. 1000

NDC 67871-772-92

GLOFIL-125 iothalamate sodium, i-125 injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67871-772 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iothalamate sodium, I-125 (Iothalamate sodium, I-125) Iothalamate sodium, I-125 1 mg

Inactive Ingredients Ingredient Name Strength benzyl alcohol sodium bicarbonate hydrochloric acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67871-772-92 4 mL (4 MILLILITER) in 1 VIAL None

Labeler — QOL Medical

Revised: 06/2007 QOL Medical